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FDA 510(k)

HM-RUBY

K-Number: K974142 · 1998-01-28

ApplicantAmerican Lasers, Inc.
Decision Date1998-01-28
Product CodeGEX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

HM-RUBY is the device name listed in this FDA 510(k) record. The listed applicant is American Lasers, Inc.. It received FDA 510(k) clearance on 1998-01-28 under 510(k) number K974142. The device is classified under product code GEX. It was reviewed by the SU advisory panel. Product code GEX falls under the category of Gastroenterology, which includes gastrointestinal diagnostic and therapeutic devices. Devices in this category are subject to specific FDA regulatory requirements. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the HM-RUBY?

HM-RUBY is a medical device that received FDA 510(k) clearance on 1998-01-28. The listed applicant is American Lasers, Inc.. The 510(k) number is K974142.

When did HM-RUBY receive FDA 510(k) clearance?

HM-RUBY received FDA 510(k) clearance on 1998-01-28, under 510(k) number K974142.

Who is the listed applicant for HM-RUBY?

The FDA 510(k) record lists American Lasers, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for HM-RUBY?

The FDA product code for HM-RUBY is GEX. This falls under the Gastroenterology category.

Other records listing American Lasers, Inc. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K061850MINI-YAG LASERK970475MM-RUBYK950826AM RUBYK950825AM-YAG

Related Devices (Code: GEX)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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